Scientist III, Quality Control (Analytical/Chemical) Sterile Operations

MannKind Corporation•Danbury, CT

About The Position

MannKind Corporation is seeking a hands-on laboratory-based individual contributor to perform analytical, physical, functional, and device-related testing supporting sterile and non-sterile drug products, including FUROSCIX® autoinjectors, pre-filled syringes, and dry powder inhalation (DPI) products. The role supports development, method transfer, validation, PPQ, commercial release, stability, investigations, and product lifecycle activities. The Scientist independently executes assigned testing, prepares samples and laboratory solutions, operates and troubleshoots instrumentation, documents and reviews data, supports or leads investigations, and provides technical support to Manufacturing, Device Development, Engineering, Validation, Quality Assurance, and Regulatory Affairs. The position conducts routine and non-routine testing on materials, components, devices, finished products, and samples; performs autoinjector, syringe, container closure integrity, and visual inspection testing; and supports method transfers, validation, stability, manufacturing, and commercial activities. It also involves authoring and reviewing controlled technical documentation, conducting root cause analysis, developing corrective and preventive actions, and supporting audits and regulatory inspections. The role requires routine work in analytical laboratories and manufacturing support areas, use of required personal protective equipment, and the ability to perform laboratory manipulations and device testing. Occasional off-shift, weekend, or holiday work may be required for time-sensitive testing, validation, investigations, or production support.

Requirements

Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline with at least 7 years of relevant experience; or a Master's degree with at least 5 years of relevant experience.
Hands-on QC analytical experience in a cGMP-regulated pharmaceutical, biotechnology, medical device, or combination-product environment.
Demonstrated practical experience with HPLC/UHPLC and other analytical or compendial techniques used for drug product testing.
Experience with analytical method transfer, validation or verification, stability testing, and laboratory investigations.
Ability and willingness to routinely perform laboratory testing, instrument setup, sample preparation, documentation, and manufacturing support activities.
Working knowledge of FDA cGMP requirements, USP requirements, ICH guidelines, data integrity principles, and controlled laboratory documentation.
Strong technical writing, investigation, problem-solving, communication, organization, and cross-functional collaboration skills.
Ability to work routinely in analytical laboratories and manufacturing support areas while wearing required personal protective equipment.
Ability to stand or sit for extended periods and perform repetitive laboratory manipulations, sample preparation, and device testing.
Ability to safely handle pharmaceutical materials, laboratory chemicals, glassware, equipment, devices, and test samples in accordance with approved procedures.
Ability to support manufacturing and testing schedules, including occasional off-shift, weekend, or holiday activities when required for time-sensitive testing, validation, investigations, or production support.

Nice To Haves

Hands-on experience testing sterile injectable drug products, pre-filled syringes, autoinjectors, or drug-device combination products.
Hands-on experience with CCIT, visual inspection, device functional testing, component testing, or test equipment qualification.
Experience testing non-sterile DPI drug products, including APSD, DDU, assay, impurities, moisture, particle size, or content uniformity.
Experience supporting PPQ, process validation, design transfer, commercial release, and stability programs.
Experience with electronic laboratory systems, chromatography data systems, LIMS, and statistical or trending tools.
Experience supporting regulatory inspections and responding to analytical, device, or laboratory-related observations.

Responsibilities

Perform routine and non-routine testing of raw materials, packaging and device components, in-process materials, finished drug products, stability samples, validation samples, and investigation samples.
Conduct analytical testing using techniques such as HPLC/UHPLC, GC, dissolution, UV-Visible spectroscopy, FTIR, Karl Fischer, particle size analysis, laser diffraction, osmolality, pH, conductivity, and density.
Prepare standards, reagents, mobile phases, buffers, sample solutions, and laboratory controls according to approved procedures.
Operate, maintain, verify, and troubleshoot analytical instruments and laboratory equipment; escalate significant equipment or method issues.
Review, interpret, calculate, and document analytical data in compliance with cGMP, procedures, and data integrity requirements.
Perform analytical, physical, and functional testing of FUROSCIX® autoinjectors, pre-filled syringes, assembled devices, and associated components.
Test device attributes including break-loose force, glide force, activation force, injection time, delivered volume or dose, dose delivery performance, needle or safety-feature performance, mechanical function, and assembly verification.
Perform dimensional, attribute, and functional testing of syringe and autoinjector components against methods, drawings, specifications, or protocols.
Set up, operate, verify, and troubleshoot device testing equipment and fixtures.
Support device design transfer, analytical method transfer, equipment qualification, process validation, PPQ, commercial readiness, stability, and lifecycle activities.
Support investigations involving device assembly, functional performance, component defects, packaging, transportation, and product complaints.
Execute or support Container Closure Integrity Testing (CCIT) for pre-filled syringes, sterile drug product containers, and autoinjector container closure systems.
Support CCIT method transfer, qualification, validation, troubleshooting, lifecycle activities, and investigations of integrity failures or atypical results.
Support qualification and evaluation of primary packaging systems, sterile barriers, and container closure components.
Perform manual or semi-automated visual inspection of sterile drug products and pre-filled syringes for visible particles, cosmetic defects, container defects, fill-related defects, and other specified attributes.
Support visual inspector qualification and requalification, defect-set development, inspection method studies, and inspection equipment qualification.
Evaluate defect classifications and trends; support investigations of visual inspection rejects, inspection failures, and atypical defect rates; document inspection results.
Execute analytical method transfers and perform method verification, qualification, validation, robustness, comparability, and equivalency studies; document results in protocols and reports.
Test engineering batches, registration batches, PPQ, commercial release, continued process verification, and stability programs.
Provide laboratory and on-floor QC support during sterile compounding, aseptic filling, device assembly, DPI manufacturing, packaging, equipment qualification, validation, and investigations.
Coordinate testing priorities and communicate results or technical risks to cross-functional stakeholders.
Lead or support OOS, OOT, deviation, laboratory, method, instrument, device, CCIT, and visual inspection investigations.
Conduct scientifically sound root cause analysis and develop or implement corrective and preventive actions.
Author and review SOPs, specifications, test methods, protocols, reports, risk assessments, change controls, and technical assessments.
Identify opportunities to improve laboratory safety, compliance, right-first-time execution, testing efficiency, and method robustness.
Support regulatory inspections, customer audits, internal audits, and inspection readiness as a technical resource.